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K Number
K992707
Device Name
MCL 29 DERMABLATE ER:YAG LASER SYSTEM
Manufacturer
AESCULAP-MEDITEC NORTH AMERICA
Date Cleared
1999-10-19

(69 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.

The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.

Device Description

The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a study.

Specifically, the document states:

  • "Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices. Because that, performance data were not required."

Therefore, I cannot fill out the requested table and information.

If there were performance data, the table would look like this:

Acceptance CriteriaReported Device Performance
[Criterion 1][Performance 1]
[Criterion 2][Performance 2]

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.